Patient Information Leaflet

Nasivin Sinus and Cold, 200 mg + 30 mg, coated tablets
Ibuprofenum + Pseudoephedrini hydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days in adolescents or after 5 days of treatment in adults, or if symptoms worsen, consult your doctor.

Table of contents

What Nasivin Sinus and Cold is and what it is used for
Important information before taking Nasivin Sinus and Cold
How to take Nasivin Sinus and Cold
Possible side effects
How to store Nasivin Sinus and Cold
Contents of the pack and other information

1. What Nasivin Sinus and Cold is and what it is used for

Nasivin Sinus and Cold contains the active substances ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), and pseudoephedrine, which acts by constricting nasal mucosal blood vessels.

Ibuprofen reduces pain and swelling and lowers elevated body temperature.
Pseudoephedrine acts on blood vessels in the nose to reduce nasal mucosal congestion.

Nasivin Sinus and Cold is indicated for the relief of nasal congestion associated with headache, fever, and/or pain in the common cold or influenza.
Nasivin Sinus and Cold is indicated for use in adults and adolescents aged 15 years and older.
This combination medicine should only be used if the patient has a blocked nose accompanied by pain or fever. Do not use this medicine if only one of these symptoms is present.
If there is no improvement or if the condition worsens after 3 days in adolescents or after 5 days of treatment in adults, consult your doctor.

2. Important information before using Nasivin Sinus and Cold

When NOT to use Nasivin Sinus and Cold:

if the patient is allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6),
in patients under 15 years of age,
during pregnancy and breastfeeding,
if the patient has ever experienced allergic reactions (such as: wheezing, bronchospasm, worsening of asthma, nasal polyps, runny nose with itching, facial swelling, urticaria or rash)

after taking aspirin (acetylsalicylic acid) or another pain-relieving, antipyretic or anti-inflammatory medicine,

if the patient has (or has had recurrent) gastric or duodenal ulcers (peptic ulcer) or bleeding (2 or more episodes of confirmed ulceration or bleeding),
if the patient has previously experienced gastrointestinal perforation or bleeding due to use of NSAIDs,
if the patient has other bleeding disorders,
if the patient has severe liver failure,
if the patient has severe acute (sudden) or chronic (long-term) kidney disease or renal failure,
if the patient has severe heart failure,
if the patient has very high blood pressure (severe hypertension) or hypertension that cannot be controlled with medication,
if the patient has severe heart or circulatory disorders (such as: coronary heart disease, heart disease, angina pectoris, rapid heartbeat), hyperthyroidism, diabetes, pheochromocytoma (adrenal gland tumour),
if the patient has suffered a myocardial infarction,
if the patient has previously had a stroke or is at risk of stroke,
if the patient has previously experienced seizures,
if the patient has unexplained blood disorders,
if the patient has glaucoma (high pressure in the eye),
if the patient has difficulty urinating and/or prostate enlargement,
if the patient has systemic lupus erythematosus (SLE) or mixed connective tissue disease (MCTD), a disease that attacks the immune system, e.g. causing joint pain and skin changes,
if the patient is taking:
aspirin (acetylsalicylic acid) (more than 75 mg per day) or other non-steroidal anti-inflammatory drugs (NSAIDs) or other painkillers or other medicines that constrict blood vessels of the nasal mucosa, e.g. phenylpropanolamine, phenylephrine or ephedrine or methylphenidate (see section "Nasivin Sinus and Cold with other medicines"),
non-selective monoamine oxidase inhibitors (known as MAO inhibitors and used in the treatment of Parkinson's disease or depression) or has taken them within the last 2 weeks (see section "Nasivin Sinus and Cold with other medicines"),
anticoagulant medicines (oral anticoagulants, heparins, antiplatelet medicines),
corticosteroids,
lithium (used in bipolar affective disorder or depression),
selective serotonin reuptake inhibitors (SSRIs) (antidepressant medicines),
high-dose methotrexate (over 20 mg per week) (an immunosuppressive medicine).

Warnings and precautions
Before starting treatment with Nasivin Sinus and Cold, consult a doctor or pharmacist:

if the patient suffers or has suffered from asthma or allergic disease; there is a risk of asthma attack,
if the patient has been diagnosed with blood clotting disorders,
if the patient has mild to moderate, well-controlled high blood pressure, heart failure or heart disease,
if the patient has psychosis,
if the patient has gastrointestinal disorders in their medical history (see section "When NOT to use Nasivin Sinus and Cold"),
if the patient has mild or moderate kidney or liver impairment,
if the patient is taking migraine medications,
if the patient has an infection - see below, section titled "Infections".

The use of anti-inflammatory and (or) pain-relieving medicines such as Nasivin Sinus and Cold may be associated with a small increased risk of heart attack or stroke, especially when high doses are used. The risk increases with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
Discontinue use of Nasivin Sinus and Cold if high blood pressure, rapid or irregular heartbeat, nausea or any neurological symptoms such as headache or worsening headache occur.
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may involve reduced blood flow to the brain. If symptoms suggestive of PRES or RCVS occur, discontinue use of Nasivin Sinus and Cold immediately and seek immediate medical help (symptoms, see section 4 "Possible side effects").
During treatment with ibuprofen, allergic reactions to this medicine have been observed, including breathing difficulties, facial and neck swelling (angioedema), chest pain. If these symptoms occur, discontinue Nasivin Sinus and Cold immediately and contact a doctor or go to an emergency department.
During treatment with Nasivin Sinus and Cold, reduced blood flow in the optic nerve may occur. If sudden vision loss occurs, discontinue use of Nasivin Sinus and Cold and contact a doctor or seek medical help immediately. See section 4.
During treatment with Nasivin Sinus and Cold, sudden abdominal pain or rectal bleeding due to inflammation of the large intestine (ischemic colitis) may occur. If such gastrointestinal symptoms occur, discontinue use of Nasivin Sinus and Cold and seek immediate medical advice or help. See section 4.
Infections
Nasivin Sinus and Cold may mask symptoms of infection such as fever and pain. Therefore, Nasivin Sinus and Cold may delay appropriate treatment of infection and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an existing infection and infection symptoms persist or worsen, consult a doctor immediately.
Before using Nasivin Sinus and Cold, discuss treatment with a doctor or pharmacist if:

the patient has heart disorders including heart failure, angina pectoris (chest pain), or if the patient has had a heart attack, coronary artery bypass surgery (bypass), peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA") (see section "When NOT to use Nasivin Sinus and Cold").
the patient has high blood pressure, diabetes or high cholesterol, family history of heart disease or stroke, or is a smoker (see section "When NOT to use Nasivin Sinus and Cold").

During treatment, avoid alcohol consumption.
Ibuprofen may cause severe allergic reactions, especially in people allergic to aspirin. Symptoms may include: urticaria, facial swelling, asthma (wheezing) and shock. Serious skin reactions have been reported, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) in connection with treatment with Nasivin Sinus and Cold. Discontinue use of Nasivin Sinus and Cold and seek immediate medical help if any skin rash, mucosal changes, blisters or other allergic symptoms occur, as these may be early signs of a very serious skin reaction. See section 4.
There is a risk of kidney function impairment in adolescents who are dehydrated.
If symptoms persist or worsen, contact a doctor.
Children and adolescents
Nasivin Sinus and Cold must not be used in children and adolescents under 15 years of age.
Nasivin Sinus and Cold with other medicines
Inform your doctor or pharmacist about all medicines currently or recently used, and any medicines you plan to use.
Do not use Nasivin Sinus and Cold with:

aspirin,
other non-steroidal anti-inflammatory drugs (NSAIDs),
other painkillers or antipyretics,
monoamine oxidase inhibitors (MAO inhibitors used in the treatment of Parkinson's disease or depression) taken within the last 14 days,
other vasoconstrictor medicines used to relieve nasal congestion (e.g. phenylpropanolamine, phenylephrine and ephedrine, methylphenidate), administered orally or intranasally,
anticoagulant medicines such as anticoagulants and antiplatelet agents (e.g. aspirin (acetylsalicylic acid), warfarin, ticlopidine),
medicines that may increase the risk of gastric ulcers or bleeding, e.g. steroids, antidepressant SSRIs (e.g. fluoxetine, paroxetine) or NSAIDs, including aspirin,
lithium,
high-dose methotrexate (over 20 mg per week).

Other medicines may affect the action of Nasivin Sinus and Cold or Nasivin Sinus and Cold may affect the action of other medicines. For example:

anticoagulant medicines (such as anticoagulants and antiplatelet agents e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine),
antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, guanethidine, reserpine and methyldopa),
medicines that may increase the risk of gastric ulcers or bleeding, e.g. steroids, antidepressant SSRIs (e.g. fluoxetine, paroxetine) or NSAIDs, including aspirin and selective cyclooxygenase (COX)-2 inhibitors,
medicines for irregular heartbeat, angina, heart failure or fluid retention (e.g. cardiac glycosides, quinidine), as Nasivin Sinus and Cold may reduce their effectiveness or increase the risk of irregular heartbeat, high blood pressure or impaired kidney function,
cyclosporine (an immunosuppressive medicine) due to possible increased risk of kidney function impairment,
medicines used in depression (lithium, tricyclic antidepressants) which may increase the risk of adverse effects,
concomitant use of phenytoin (an anticonvulsant) may increase serum levels of these medicines. Monitoring of phenytoin blood levels is not generally required for proper use (maximum for 5 days),
other medicines that constrict the mucosa or suppress appetite, as they may increase the risk of adverse effects,
reversible inhibitors of monoamine oxidase A (RIMA, used in depression), linezolid (an antibiotic) and ergot alkaloids (used in Parkinson's disease) may increase the risk of high blood pressure,
probenecid or sulfinpyrazone may delay ibuprofen excretion,
sulfonylurea derivatives (antidiabetic medicines): although interactions with ibuprofen have not been described to date, blood glucose levels should be checked as a precaution during concomitant use,
diuretics (medicines that increase urine output),
high-dose methotrexate (over 20 mg per week), as it may enhance methotrexate effects,
quinolone antibiotics due to increased risk of seizures,
tacrolimus, trimethoprim, corticosteroids,
migraine medicines,
zidovudine (used in HIV infection treatment), terpene derivatives, clobutinol, anticholinergic-like substances and local anaesthetics that may increase the risk of seizures,
heparin by injection or (and) medicinal products containing Ginkgo biloba due to increased risk of bleeding.

Other medicines may also affect the action of Nasivin Sinus and Cold and Nasivin Sinus and Cold may affect the action of other medicines. Therefore, always consult a doctor or pharmacist before using Nasivin Sinus and Cold together with other medicines, including those available without a prescription.
In the perioperative period, acute hypertensive reaction may occur due to pseudoephedrine use. Therefore, discontinue Nasivin Sinus and Cold several days before planned surgery and inform the anaesthesiologist.
Nasivin Sinus and Cold with food and drink
Take tablets with water, preferably after a meal.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Nasivin Sinus and Cold must not be used during pregnancy.
Active substances: ibuprofen and pseudoephedrine may cause serious disorders in unborn children.
Non-steroidal anti-inflammatory drugs (NSAIDs) may cause kidney and heart function disorders in the unborn child. They may increase the tendency to bleeding in both mother and child and may delay or prolong labour.
From the 20th week of pregnancy, non-steroidal anti-inflammatory drugs (NSAIDs) may result in kidney function disorders in the unborn child, which may lead to low levels of amniotic fluid surrounding the child (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the child's heart.
Breastfeeding
Active substances, ibuprofen and pseudoephedrine, have been detected in breastfed infants of women taking them.
Therefore, Nasivin Sinus and Cold must not be used during breastfeeding.
Effect on fertility
Nasivin Sinus and Cold contains ibuprofen, which belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after discontinuation of the medicine.
Driving and operating machinery
No effect of Nasivin Sinus and Cold on the ability to drive and operate machinery has been observed. However, consider the possibility of dizziness or hallucinations.
Nasivin Sinus and Cold contains:

Sodium - this medicine contains 1.65 mg of sodium per tablet. This should be taken into account in patients on a controlled sodium diet.

Use of pseudoephedrine may lead to positive results in anti-doping tests.

3. How to use Nasivin Zatoki i Katar

This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Nasivin Zatoki i Katar is intended for oral use only.
Recommended dose:
Adults and adolescents aged 15 years and above: 1 tablet every 4–6 hours, as needed. In case of
more severe symptoms, 2 tablets every 6–8 hours, as needed.
Do not exceed the maximum daily dose of 6 tablets.
Tablets should be swallowed whole with water, preferably after a meal. Do not break or crush the tablets.
Nasivin Zatoki i Katar should only be used when both nasal congestion and headache and/or fever
are present simultaneously. If the patient has only one of these symptoms (nasal congestion or
headache and/or fever), consult a doctor or pharmacist for an alternative treatment option.
In patients over 60 years of age, treatment should be initiated at the lowest possible dose due to an
increased risk of gastrointestinal bleeding, ulceration, or perforation.
Your doctor may recommend concomitant use of gastroprotective agents together with Nasivin Zatoki i Katar
if the patient belongs to this age group.
Consult your doctor if the patient has mild or moderate chronic kidney or liver disease, as dose
adjustment may be necessary based on the patient's condition.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If, during the course of infection, symptoms (such as fever and pain) persist or worsen, consult your
doctor immediately (see section 2).
Use in children and adolescents
Do not use in children and adolescents under 15 years of age.
Duration of treatment
This medicine is intended for short-term use only. Use the lowest effective dose for the shortest
duration necessary to relieve symptoms.
Do not exceed 5 days of treatment in adults.
Do not exceed 3 days of treatment in adolescents (aged 15–18 years).
If symptoms persist or worsen, contact your doctor.
Taking more than the recommended dose of Nasivin Zatoki i Katar
If a patient takes more than the recommended dose of ibuprofen or pseudoephedrine, or if the medicine
is accidentally ingested by a child, always contact a doctor or the nearest hospital immediately for
information on risks and necessary actions.
Symptoms of overdose may include nausea, abdominal pain, vomiting (including vomiting with visible
blood streaks), headache, tinnitus, uncoordinated and involuntary eye movements.
Following large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in
children), weakness and dizziness, blood in urine, feeling cold, and breathing difficulties have been
reported.
Missed dose of Nasivin Zatoki i Katar
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should STOP USING this medicine IMMEDIATELY and contact your doctor without delay:

if you experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS), including:
- sudden, severe headache,
- nausea,
- vomiting,
- confusion,
- seizures,
- visual disturbances.
if you experience any of the following symptoms, which may indicate severe allergic reactions:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- severe skin itching with hives
- severe skin reactions, including subcutaneous blisters
- rapid heartbeat with low blood pressure
if you experience symptoms of gastrointestinal bleeding:
- bright red stools, feeling of weakness, bloody or black tarry stools, persistent abdominal pain, vomiting blood or dark particles resembling coffee grounds

Other adverse effects:
Not common (may affect up to 1 in 100 patients):

headache, dizziness, difficulty sleeping, restlessness, irritability or fatigue
visual disturbances
dry mouth, thirst
gastrointestinal discomfort, nausea, vomiting, diarrhoea, loss of appetite, indigestion (heartburn)

Rare (may affect up to 1 in 1,000 patients):

tinnitus (ringing in the ears)
nervousness, tremor, anxiety, restlessness, agitation, insomnia
worsening of asthma, wheezing
allergic reaction with bronchospasm (shortness of breath)
abdominal pain, bloating, constipation
oedema, hypertension (high blood pressure), palpitations, heart failure, irregular heartbeat, rapid pulse, chest pain, heart attack
kidney tissue damage, increased blood urea concentration
rash, urticaria, itching, redness, excessive sweating

Very rare (may affect up to 1 in 10,000 patients):

gastric/duodenal ulcer disease (peptic ulcer), sometimes with bleeding or perforation (blood in vomit or stools), gastritis, oral ulceration, exacerbation of colitis and Crohn's disease
liver disorders, particularly during long-term treatment, liver failure, acute hepatitis
infectious inflammatory conditions, symptoms of aseptic meningitis (headache, fever, neck stiffness, nausea, vomiting or disorientation), especially in patients with existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease), blood disorders (anaemia, leukopenia, neutropenia, thrombocytopenia, pancytopenia,

agranulocytosis). Initial symptoms include: fever, sore throat, superficial oral ulcers,
flu-like symptoms, severe fatigue, unexplained nosebleeds and bruising

severe allergic reactions (symptoms may include facial swelling, angioedema, shortness of breath, bronchospasm, rapid pulse, low blood pressure, anaphylactic shock)
psychotic reactions, depression
kidney failure or other kidney function disorders, increased serum creatinine concentration
oesophagitis (heartburn), pancreatitis, intestinal stricture resembling diaphragm disease
red, flat, target-like or circular skin lesions on the trunk, often with central blisters, skin peeling, ulceration in the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
hair loss, severe skin infections, soft tissue complications in chickenpox

Frequency not known (frequency cannot be estimated from available data)

severe conditions affecting cerebral blood vessels, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
reduced blood flow in the optic nerve, which may lead to vision loss or concentration problems (ischaemic optic neuropathy)
dilated pupils
increased blood glucose concentration
drug reaction with eosinophilia and systemic symptoms: a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophil count (a type of white blood cell). If such symptoms occur, discontinue use of this medicine and seek immediate medical help.
red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis, AGEP). If such symptoms occur, stop taking Nasivin Zatoki i Katar and seek immediate medical help. See also section 2.
inflammation of the large intestine due to insufficient blood supply (ischaemic colitis)
stroke
intestinal disorders which may cause sudden pain or rectal bleeding
seizures
difficulty urinating in men with benign prostatic hyperplasia
hallucinations, abnormal behaviour
skin becomes sensitive to light (photosensitivity reactions)
chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome

Medicines such as Nasivin Zatoki i Katar may be associated with a small increased risk of heart attack or
stroke.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie
181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects can also be reported to the responsible entity.

5. How to store Nasivin Sinus and Cold

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP" or
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Nasivin Zatoki i Katar contains

Active substances: ibuprofen (200 mg per tablet) and pseudoephedrine hydrochloride (30 mg per tablet, equivalent to 24.6 mg of pseudoephedrine).
Other ingredients: microcrystalline cellulose, pregelatinized corn starch, povidone K-30, colloidal anhydrous silica, stearic acid 95, sodium croscarmellose, sodium lauryl sulfate; Opadry Yellow: hypromellose, titanium dioxide (E 171), polyethylene glycol 400, yellow iron oxide (E 172), polysorbate 80, red iron oxide (E 172), black iron oxide (E 172); Opadry fx Silver: partially hydrolyzed polyvinyl alcohol, talc (E 553b), polyethylene glycol 3350, "MICA-Based Pearlescent Pigment" containing: potassium aluminium silicate (E 555), titanium dioxide (E 171); polysorbate 80.

(For further information regarding sodium, see the end of section 2).
What Nasivin Zatoki i Katar looks like and contents of the pack
Nasivin Zatoki i Katar is a yellow, oval-shaped, biconvex tablet (dimensions: approximately 15.6 mm x 7.7 mm).
Tablets are available in blister packs of 12, 20 and 24 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Wick Pharma Zweigniederlassung der Procter & Gamble GmbH
Sulzbacher Str.40
65824 Schwalbach am Taunus
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Procter & Gamble Health Poland Sp. z o.o.
ul. Zabraniecka 20, 03-872 Warsaw
tel. 801 25 88 25
Manufacturer:
P&G Health Austria GmbH & Co. OG,
Hösslgasse 20,
9800 Spittal an der Drau,
Austria
This medicinal product is authorised in the following names in the Member States of the European Economic Area:
Italy: Vicks Flu Action 200 mg/30mg compresse rivestite con film
Austria: WICK DayMed Duo 200mg/30mg Filmtabletten
Germany: WICK DuoGrippal 200 mg/30 mg Filmtabletten
Spain: SinusVicks 200mg/30mg comprimidos recubiertos con película
Hungary: Nassin Sinus 200 mg/30 mg filmtabletta
Poland: Nasivin Zatoki i Katar
Romania: Ibuprofen/Pseudoefedrina Wick 200 mg/30 mg comprimate filmate

Nasivin for congestion and catarrh